healthcare-projects
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Risk Management Plan
Coffee Machine
1. General Informations
1.1 Responsibilities:
The creation of this risk management process took place in the risk management
team consisting of MANAGING DIRECTOR, QUALITY MANAGER, HEAD OF
MANUFACTURING, DESIGN MANAGER, QUALITY MANAGER, a process
independent person. The release is documented on page 9.
The documentation was created by QUALITY MANAGER / Mr. Dr. Frank Stein.
Date:
Name Sign:
1.2 Scope:
This management plan is valid for the coffee machine manufactured by the
Healthcare projects GmbH.
The coffee machine is a machine to brew coffee for customers / users older as 14
years.
The risk analysis refers to the following life cycle stages:
 Material
 Design
 Manufacturing Process
 Sterilization Process
 Packaging
 Labeling
 Logistics and Shipping
 Handling before and in the surgery process
 PMS
1.3 Verification:
Risk analysis is checked once a year at least in the context of the management
review together with the results of the Post market surveillance. Relevant changes in
the manufacturing process or serious incidents, a re-evaluation takes place
immediately.
1.4 Risk Analysis
The goal is:
The collection of available information on the identification of hazards and
assessment of the risks associated with the coffee machine.
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Risk Management Plan
Coffee Machine
 The collection of available information on the identification of hazards and
assessment of the risks associated with the coffee machine
 The definition of intended use
 Identification of hazards.
 The risk assessment.
Risk analysis is created in the risk analysis form.
The definitions and risk analysis / risk assessment process is described in SOP:
GF110200.
The valuation is in accordance with DIN EN ISO 14971:2012 part 4 and Appendix D
with product-specific adaptation.
1.5 Risk assessment:
Measures in accordance with DIN EN ISO 14971:2012 part 5 and Appendix D with
product-specific adaptation.
The acceptability of the risks is assessed after an assessment matrix of probability of
occurrence and severity (harm).
1.6 Risk control
The acceptability of residual risks will be assessed after the evaluation matrix of
probability of occurrence and severity (harm).
The risk is in accordance with DIN EN ISO 14971:2012 part 6 and Appendix D with
product-specific adaptation.
The risk consists of the following:
 Risk mitigation
 Implementation of measures
 Assessment of the residual risk
 Acceptability of the overall risk
These points are processed in the risk analysis.
1.7 Risk management report
The review of implementation of planned risk management procedures.
2. Risk analysis
2.1 Definition of the intended use
Product description
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healthcare-projects
example document
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Risk Management Plan
Coffee Machine
The coffee machine is an electrical device working with 230 V / 50 Hz, 1.500 W
electrical power. The housing / case of the machine is from thermostabil hard plastic,
contain a water heating and boiling module, a warming plate for the coffee cup, a
reservoir with filter to brew coffee from coffee powder and boiled water.
 The machine brew coffee
 Keep coffee warm
Warnings
 Keep away the coffee machine from children
 Keep away the coffee machine from wet places
 Do not use the machine, if a damage is visible
 Do not use the machine, if you did not read the instruction manual
All necessary instructions and warning information located on the packaging and in
the Instruction For Use. (IFU)
2.2 Sources of danger
The sources of risk will be assessed for the following possible processes / product
phases:
1. Production (including raw materials)
2. Primary packaging
3. Secondary packaging
4. Labelling / use info
5. Storage / shipping
6. Logistics up to the OP
7. Handling the coffee machine
8. Implementation of the OP and PMS
2.3 List of possible hazards (main)
 Energy harzards
 Biological harzards
 Exposure harzards arising from the operation
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Risk Management Plan
Coffee Machine
 Information harzards
 Risks of triggering events and circumstances
2.4 Risk-Assessment
Set at the beginning of the following principles for the evaluation of the risk analysis:
 The assessment assumes a dedicated application (intended use). For other
applications, the Healthcare projects GmbH assumes no liability.
 The assessment assumes a handling of the coffee machine by trained personnel
(skilled personnel). Healthcare projects GmbH assumes no liability for handling by
untrained personnel.
2.4.1 Order
It is so to proceed that the listed possible threats are processed one after the other,
and before introduction of measures and then after the imposition of measures. This
is represented in the tabular risk analysis
For each potential hazard, it is set in what danger she could occur. The potential
risks and the resulting impact on the persons involved are valued for the resulting
couples (hazard / source). Then, measures to be taken may be elaborated.
2.4.2 Risk Assessment
The following factors are used as valuation bases for determining the risks:
 The severity of the impact on stakeholders Rating scale: 1 (no effect) to 10 (death)
1
2
3
4
5
6
7
8
9
10










No effect (E.g. replacement before use)
Very low (E.g. coffee taste a little bit strange)
Low (E.g. coffee taste medium strange e.g. is cold)
Low - medium (machine is not working and need a replacement)
Medium (machine damage the environment but no person is injured)
Medium - heavy ( user is light injured)
Hard (user is heavy injured)
Very heavy (user is injured and get a disability)
Extremely heavy (user is injured and get a hard disability)
Death of user
 The probability of the occurrence Rating scale: 1 (never) to 10 (always)
1
2
3
4




Never (0%)
Very low (< 2%)
Low (< 5%)
Low - medium (< 10%)
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5
6
7
8
9
10






Risk Management Plan
Coffee Machine
Medium (< 15%)
Medium - often (< 20%)
Often (< 33%)
Very often (< 50%)
Extremly often (< 100%)
Ever (100%)
2.5 Risk assessment
The risk rating is determined with the help of the evaluation matrix of the two factors:
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Risk Management Plan
Coffee Machine
S E V ER IT Y L EV E L (D AM AG E L EV E L)
PR O B AB ILI T Y O F T H E O R RC UR R EN C E
(Version 1.1)
Evaluation matrix to
1
no effect
decide the acceptance or
rejection of risks (and
risk / benefit analysis)
Replacement
2
very low
3
low
4
low - medium
5
Medium
6
medium - heavy
7
hard
8
very heavy
9
extremely heavy
10
death
before use
coffee taste a
little bit strange
coffee taste
medium
strange e.g. is
cold
machine is not
working and
need a
replacement
machine
damage the
environment
but no person is
injured
user is light
injured
user is
heavy
injured
user is
injured
and get a
disability
user is injured
and get a hard
disability
Dead of user
10 – EVER
(100%)
ALARP (20)
ALARP (26)
not acceptable
(65)
not acceptable
(67)
not acceptable
(70)
not acceptable (74)
9 – extremely often
(< 100%)
ALARP (19)
ALARP (25)
ALARP (32)
not acceptable
(66)
not acceptable
(69)
not acceptable (73)
8 – very often (<
50%)
ALARP (18)
ALARP (24)
ALARP (31)
ALARP (38)
not acceptable
(68)
not acceptable (72)
7 – often (< 33%)
ALARP (17)
ALARP (23)
ALARP (30)
ALARP (37)
ALARP (44)
not acceptable (71)
6 - medium - often (<
20%)
ALARP (16)
ALARP (22)
ALARP (29)
ALARP (36)
ALARP (43)
ALARP (50)
5 – medium (< 15%)
acceptable
(5)
ALARP (21)
ALARP (28)
ALARP (35)
ALARP (42)
ALARP (49)
ALARP (55)
4 - low - medium (<
10%)
acceptable
(4)
acceptable (9)
ALARP (27)
ALARP (34)
ALARP (41)
ALARP (48)
ALARP (54)
ALARP
(59)
not acceptable
(86)
3 – low (< 5%)
acceptable
(3)
acceptable (8)
acceptable (12)
ALARP (33)
ALARP (40)
ALARP (47)
ALARP (53)
ALARP
(58)
ALARP (62)
2 – very low (< 2%)
acceptable r
(2)
acceptable (7)
acceptable (11)
acceptable (14)
ALARP (39)
ALARP (46)
ALARP (52)
ALARP
(57)
ALARP (61)
ALARP (64)
1 - never (0%)
acceptable
(1)
acceptable (6)
acceptable (10)
acceptable (13)
acceptable (15)
ALARP (45)
ALARP (51)
ALARP
(56)
ALARP (60)
ALARP (63)
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not
acceptable
(79)
not
acceptable
(78)
not
acceptable
(77)
not
acceptable
(76)
not
acceptable
(75)
not
acceptable
(85)
not
acceptable
(84)
not
acceptable
(83)
not
acceptable
(82)
not
acceptable
(81)
not
acceptable
(80)
not acceptable
(92)
not acceptable
(91)
not acceptable
(90)
not acceptable
(89)
not acceptable
(88)
not acceptable
(87)
not
acceptable
(100)
not
acceptable
(99)
not
acceptable
(98)
not
acceptable
(97)
not
acceptable
(96)
not
acceptable
(95)
not
acceptable
(94)
not
acceptable
(93)
healthcare-projects
example document
for
training
Risk Management Plan
Coffee Machine
The necessity of the measures be evaluated according to the following table.
Range
Assessment
Measures
Acceptable Range
Risk acceptable
No measures
ALARP Range
Risk mitigation
required
Preventive measures are taken into
consideration
Not Acceptable Range
Risk not acceptable
Preventive measures must be taken
ALARP = As low as reasonable possible
2.6 Risk Governance
2.6.1 Conduct the risk
If the risk assessment of a risk are in "ALARP" or "not acceptable", should or must be
carried out risk mitigation. Measures are to be searched for the two risk factors:
 Reduce occurrence frequency
 Reduce Severity/extent of damage
One or more of the following choices for the risk control in the order that is listed must
be used for each factor:
a) integrated security by design;
b) protective measures in the medical product itself or in the manufacturing process;
c) avoiding new risks by taking an action;
d) information about security.
2.6.2 The residual risk assessment
After the implementation of risk mitigation, risk analysis for the residual risks must be
carried out.
2.6.3 Risk / benefit analysis
Of danger, whose residual risk after the evaluation is still in "ALARP" or "not
acceptable" and other measures of risk control are not possible, may data, and
literature are collected and evaluated to determine whether the medical benefits of the
purpose outweighs the residual risk. If this evidence supports not the conclusion, that
the medical benefits outweigh the risk, remains the risk as unacceptable.
2.6.4 Total residual risk assessment
The results of the evaluation of the total residual risk must be recorded in the risk
management file.
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3. Create risk analysis
Risk analysis is created in the form and the details of the factors for the recognition
are set out in the risk analysis.
4. Release risk analysis
Are responsible for the release of the tabular risk analysis:
MANAGING DIRECTOR, QUALITY MANAGER, HEAD OF MANUFACTURING, SIB,
RA
5. Risk management report
In the report, the proof must be submitted that the following is carried out:
 The risk management plan has been implemented suitable
 The total residual risk is acceptable
 Appropriate methods exist, to obtain relevant information from the production
and the manufacture of downstream phases
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__________________
(Date)
__________________
Risk Management Plan
Coffee Machine
__________________
__________________
(Date)
(Date)
__________________
__________________
HEAD OF MANUFACTURINGMANAGING DIRECTORQUALITY
__________________
(Date)
__________________
MANAGER
__________________
__________________
(Date)
(Date)
__________________
__________________
BdVAL / QUALITY MANAGERA DESIGN MANAGER
Process-independent
The material has been developed with the support from the European Social
Found project “Support for RTU PhD study program provision” (agreement
2009/0144/1DP/1.1.2.1.2/09/IPIA/VIAA/005)
Šis materiāls ir izstrādāts ar Eiropas Sociālā fonda atbalstu projektā «Atbalsts
RTU doktora studiju īstenošanai».
(Vienošanās nr. 2009/0144/1DP/1.1.2.1.2/09/IPIA/VIAA/005)
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